BS EN ISO 11979-10:2018 – TC:2020 Edition
$186.33
Tracked Changes. Ophthalmic implants. Intraocular lenses – Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 71 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 47 | National foreword |
| 49 | European foreword |
| 51 | Foreword |
| 52 | Introduction |
| 54 | 1 Scope 2 Normative references |
| 55 | 3 Terms, definitions and abbreviated terms 3.1 Terms and definitions 3.2 Abbreviated terms 4 Optical requirements 5 Mechanical requirements 6 Biocompatibility requirements 7 Shelf-life and transport stability requirements 8 Fundamental requirements |
| 56 | 9 Justification for a clinical investigation 10 General clinical requirements 10.1 General 10.2 Design of a clinical investigation 10.2.1 Requirements for all types of phakic IOLs 10.2.2 Additional requirements for PTIOLs |
| 57 | 10.2.3 Additional requirements for PMIOLs 10.3 Characteristics 10.3.1 General 10.3.2 Characteristics applying to the clinical evaluations for all types of phakic IOLs |
| 58 | 10.3.3 Additional characteristics applying to PTIOLs 10.3.4 Additional characteristics applying to PMIOLs 10.4 Duration of the investigation 10.5 Enrolment 10.6 Bilateral implantation |
| 59 | 10.7 Surgical technique 10.8 Examination and treatment of subjects 10.9 Adverse events reports 10.10 Inclusion and exclusion criteria 10.10.1 General criteria for all phakic IOLs |
| 62 | 10.10.2 Additional criteria for PTIOLs 10.10.3 Additional criteria for multifocal IOLs 11 Information supplied by the manufacturer |
| 63 | Annex A (informative) Elements in a phakic IOL clinical investigation |
| 69 | Annex B (informative) Statistical methods and sample size calculations |
| 70 | Bibliography |
